Epidemiological Study in Thai Participants With Hypertension | NCT02467855

Studies
Epidemiological Study in Thai Participants With Hypertension

NCT02467855

Sponsor

Takeda

Status

Completed

Last Update Posted

Nov 13, 2015Estimated

Enrollment

2,071Actual

Phase

Not provided

Conditions

Hypertension

Interventions

No Intervention

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Apr 23, 2015

First Submission Date that Met QC Criteria

Jun 5, 2015

First Posted Date

Jun 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2015

Last Update Posted Date

Nov 13, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate blood pressure (BP) goal attainment in adult participants with essential hypertension.

Detailed Description

This study has been designed as a non-interventional, observational study to obtain information on hypertension treatment regimens and how well hypertension is controlled in Thai patients in real-life settings. Antihypertensive medications prescribed in this study will be at the discretion of the investigator and the standard of care practice at the particular study site.

The study will enroll approximately 2000 patients. Participants with well-controlled hypertension on their current antihypertensive therapy will participate in the study for only 1 visit. Participants with history of hypertension who are uncontrolled on the current antihypertensive medications or participants with newly diagnosed hypertension (diagnosed within the past 4 weeks and uncontrolled on antihypertensive therapy) will be observed over the course of 12-16 weeks. These participants will make 3 visits to the study site.

This multi-centre trial will be conducted in Thailand.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,071Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cross-Sectional Cohort		Participants receiving standard of care for hypertension with well-controlled hypertension will participate in 1 visit.	Other: No Intervention
Longitudinal Cohort		Participants receiving standard of care for hypertension with history of hypertension who are uncontrolled on the current antihypertensive medications or participants with newly diagnosed hypertension (diagnosed within the past 4 weeks and uncontrolled on antihypertensive therapy) will be observed over the course of 12-16 weeks.	Other: No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention	Other	No intervention was administered in this study.	Cross-Sectional Cohort Longitudinal Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants with Controlled Treated Hypertension		Up to 16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants for Whom Dose of Current Medications was Increased		Up to 16 weeks
Percentage of Participants for Whom Antihypertensive Medications were Switched		Up to 16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability to provide written informed consent
Age above 18 years.
Participants with essential hypertension as per European Society of Hypertension/European Society of Cardiology (ESH/ESC) criteria in general, target blood pressure (BP), systolic blood pressure (SBP) <140 and diastolic blood pressure (DBP) <90 mmHg, in diabetes, target BP, SBP <140 and DBP <85 mmHg, in renal disease with overt proteinuria (urine albumin excretion > 300 mg/day or 200 microgram/min), target BP, SBP <130 and DBP <90 mmHg).

Essential Hypertension will be defined based on the criteria established by the ESH/ESC 2013 criteria:

Grade 1 Essential hypertension - Systolic blood pressure (SBP) 140 - 159 mmHg and/or diastolic blood pressure (DBP) 90-99 mmHg with no identifiable cause
Grade 2 Essential hypertension - SBP 160 - 179 mmHg and/or DBP 100 - 109 mmHg with no identifiable cause
Grade 3 Essential hypertension-SBP ≥ 180 and/or DBP ≥ 110 mmHg with no identifiable cause.

Exclusion Criteria:

Female participants who are breastfeeding or pregnant or who are intending to become pregnant.
Has known or suspected secondary hypertension.
Is currently enrolled in or has not yet completed at least 30 days since ending an investigational product or device study or is receiving other investigational agents.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Participants with essential hypertension will be enrolled from outpatient hospital departments or hospital clinics in Thailand.

Sampling Method

Probability Sample

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases